Ambien Warning From FDA Prompts Dose Concerns, Driving Worries

Controversial sleep aid Ambien prompted a warning from the FDA after the drug was found to be processed more slowly through the body than previously believed — particularly in women.

The FDA’s Ambien warning comes as the drug (sold under the generic name zolpidem) comes under increased scrutiny and concern due to some of its more worrying side effects.

The Ambien warning was sparked by findings revealed by testing of Ambien users, which discovered that the drug was present in far higher levels in the morning that had been initially believed, and that driving even hours after the medication had been taken the night before could be affected by the lingering effects of Ambien.

Of the Ambien warning, the Food Drug Administration’s Center for Drug Evaluation and Research’s Dr. Ellis Unger explains that all patients should examine the literature and drug facts for Ambien — and indicates that the dosage recommendations for the drug have been cut by half to lower the risk of sleep drug-addled drivers inadvertently causing accidents:

“Patients should also read the medication guides and understand the benefits and risks of these drugs … We believe that by lowering these doses, we can decrease the side effects that happen the morning after.”

“In its announcement, the FDA noted that ‘some patients may be high enough the morning after use to impair activities that require alertness, including driving’ and said that ‘patients with high levels of zolpidem can be impaired even if they feel fully awake.’ The FDA has received 700 reports of zolpidem leading to “impaired driving ability and/or road traffic accidents.’ “

The recent Ambien warning is not the first time the sleep aid has come under scrutiny, and a previously undertaken study seemed to suggest that users of sleep aids like zolpidem have a five times higher overall risk of “early death” of multiple causes — but it was unclear how or if the use of insomnia medications factored into the risk.